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NCT Number: NCT06172933

A Text- and Audio-based Intervention to Promote Physical Activity in Midlife

This is a randomized, controlled pilot trial (N=30) to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Middle Aged Behavior Motor Activity

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

This is a randomized, controlled pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults. In Move with Meaning, participants will listen to weekly audio sessions and complete twice weekly text message sessions, in which they will set a weekly physical activity goal. The primary outcome is feasibility (measured by number of successful text message sessions sent). Secondary outcomes include acceptability and preliminary impact on physical activity, psychological health-, and physical health-related outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Midlife adults (aged 45-64 years at the time of enrollment)
  • Suboptimal physical activity (<150 minutes of moderate to vigorous physical activity, measured by accelerometer)
  • Access to a phone capable of receiving text messages and listening to audio files (i.e., a smartphone)

Exclusion criteria

  • An unrelated condition limiting physical activity
  • Participation in any other programs focused on cardiac prevention or well-being
  • A cognitive disturbance precluding participation or informed consent
  • Current pregnancy
  • Inability to speak/write fluently in English

Treatment and study plan

Move with Meaning

Behavioral

Participants will engage in twice weekly text message sessions, will listen to a weekly audio session, and will work towards a physical activity goal each week, for a total of eight weeks.

Primary outcomes

  1. Proportion of text message sessions successfully delivered

    Time frame: Weekly over 8 weeks

    The automated platform will record rates of successful text message delivery.

Secondary outcomes

  1. Proportion of audio sessions completed by participants

    Time frame: Weekly over 8 weeks

    We will record the number of sessions in which participants engaged (e.g., responded to a text message), out of a total of 8 sessions.

  2. Session utility

    Time frame: Weekly over 8 weeks

    Participants will rate the utility of each session, measured on a 10-point Likert scale. Higher scores indicate greater utility.

  3. Change in overall physical activity (in steps/day)

    Time frame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)

    Physical activity (steps) will be measured via an Actigraph accelerometer. We will use established accelerometer protocols to measure the mean number of steps taken per day at each time point.

  4. Change in moderate to vigorous physical activity (MVPA; in mean minutes/day)

    Time frame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)

    MVPA (reported in mean minutes of MVPA/day) will be measured via an Actigraph accelerometer and recorded in mean minutes/day.

  5. Change in sedentary time (in mean minutes/day)

    Time frame: Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)

    Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer.

  6. Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week)

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity.

  7. Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    Positive affect (our main psychological outcome given its links to health outcomes and sensitivity to change) will be assessed via the Positive and Negative Affect Schedule (PANAS) positive affect items. PANAS scores range from 10-50, with higher scores indicating higher levels of positive affect.

  8. Change in optimism (Life Orientation Test - Revised [LOT-R])

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    Optimism will be measured using the Life Orientation Test - Revised (LOT-R), a frequently used 6-item instrument that assesses dispositional optimism. LOT-R scores range from 0-24, with higher scores indicating higher levels of optimism.

  9. Change in depressive symptoms (depression subscale of the Hospital Anxiety and Depression Scale [HADS]).

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    Depressive symptoms will be measured using the 7-item depression subscale of the Hospital Anxiety and Depression Scale (HADS). The depression subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of depression.

  10. Change in anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale [HADS])

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    Anxiety will be measured using the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of anxiety.

  11. Change in exercise self-efficacy (Self-Efficacy for Exercise scale [SEE])

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    Exercise self-efficacy will be measured via the Self-Efficacy for Exercise (SEE) scale. SEE scores range from 0-90, with higher scores indicating higher levels of self-efficacy for exercise.

  12. Change in perceived social support (Multidimensional Scale of Perceived Social Support)

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    Perceived social support will be measured by the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS scores range from 1-7, with higher scores indicating higher levels of perceived social support.

  13. Change in internal health locus of control (Multidimensional Health Locus of Control [MHLC] scale)

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    Internal locus/sense of control will be measured using the Multidimensional Health Locus of Control (MHLC) scale. The internal locus of control score from the MHLC ranges from 6-36, with higher scores indicating greater internal locus of control.

  14. Change in positive affect during activity (Physical Activity Enjoyment Scale)

    Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

    Positive affect during activity will be measured using the Physical Activity Enjoyment Scale. Physical Activity Enjoyment Scale scores range from 18-126, with higher scores indicating higher levels of enjoyment during activity.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2023
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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